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Clinical Trials/NCT05434429
NCT05434429
Unknown
Not Applicable

Evaluating the Effectiveness of a Smartphone App to Reduce Craving and Lapse Risk in Problematic Behaviors and Substance Use

PredictWatch1 site in 1 country600 target enrollmentJune 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Addiction
Sponsor
PredictWatch
Enrollment
600
Locations
1
Primary Endpoint
Craving level according to EMA self-report
Last Updated
3 years ago

Overview

Brief Summary

The aim of the study is to evaluate the effectiveness of long-term and short-term app-based self-guided psychological interventions to reduce craving and lapse risk in problematic behaviors (compulsive sex, pornography, overeating, gaming, gambling) and substance use (cannabis, nicotine). Participants are randomly assigned to either the intervention group or the control. Participants in the intervention group have access to short-term and long-term interventions, whereas those in the control group only have access to the weekly ecological momentary assessment reports. Participants in the intervention group are able to access the intervention materials 5 days after enrollment and receive weekly ecological momentary assessment reports. Those in the control group will be granted access to all intervention materials after five weeks following study enrollment. A questionnaire battery assessments is administered (1) at baseline in the first week following onboarding in; (2) after 5 weeks; (3) after six months. In addition, longitudinal data on several variables related to craving and lapse risk are collected daily using ecological momentary assessment

Detailed Description

The aim of the study is to evaluate the effectiveness of long-term and short-term app-based self-guided psychological interventions to reduce craving and lapse risk in problematic behaviors and substance use. Two main self-guided intervention modules are available. Short-term self-guided intervention module include mainly audio-guided sessions on gratitude, thoughts management, auto-empathy, and relaxation. Moreover, there based on breath relaxation exercises, craving management, and motivation to change Long-term self-guided intervention module include CBT-based interventions, meditations, mindfulness, and journaling. Participants are recruited via newsletters, local and nation-wide advertisements, as well as through social media. The study is conducted via a mobile application "Nałogometr", freely available to participants. We recruit people from the general population residing in Poland. To compare the effectiveness of mobile app-based self-guided psychological interventions, study participants are randomly assigned to either the intervention group or the control. Experimental conditions are balanced based on multiple variables provided during onboarding: (1) main addiction type; (2) participation in addiction-related therapy; (3) gender; (4) age; (5) addiction severity; (6) abstinence duration. Participants in the intervention group have access to short-term and long-term interventions, whereas those in the control group only have access to the weekly ecological momentary assessment reports. Participants in the intervention group will be able to access the intervention materials 5 days after enrollment and will receive weekly ecological momentary assessment reports. Those in the control group will be granted access to all intervention materials after five weeks following study enrollment. Questionnaire battery assessments will take place: (1) at baseline in the first week following onboarding in; (2) after 5 weeks; (3) after six months. In addition, longitudinal data on several variables related to craving and lapse risk will be collected daily using ecological momentary assessment.

Registry
clinicaltrials.gov
Start Date
June 21, 2022
End Date
February 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
PredictWatch
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • are at least 18 years of age
  • speak Polish fluently
  • use either an Android or iOS smartphone

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Craving level according to EMA self-report

Time Frame: 5 weeks

Collected daily via the participant's smartphone; an item asking how strong is one's urge to use \[substance\] at the moment on a scale of 0 to 6 (none - incalculable ). The score will be tracked for changes over time.

Lapses rate according to EMA self-report

Time Frame: 5 weeks

Collected daily via the participant's smartphone; an item asking whether or not the lapse occurred since the last survey (yes / no). The score will be tracked for changes over time.

Secondary Outcomes

  • Severity of Dependence Scale(1 week, 5 weeks, 6 months)
  • Brief Pornography Screen-PL(1 week, 5 weeks, 6 months)
  • Compulsive Sexual Behavior Disorder(1 week, 5 weeks, 6 months)
  • Binge Eating Disorder Screener-7(1 week, 5 weeks, 6 months)
  • Drug Use Disorders Identification Test(1 week, 5 weeks, 6 months)
  • The Cannabis Use Disorder Identification Test - Revised(1 week, 5 weeks, 6 months)
  • The Hospital Anxiety Depression Scale(1 week, 5 weeks, 6 months)
  • The Fagerstrom Test for Nicotine Dependence(1 week, 5 weeks, 6 months)
  • Satisfaction with Life Scale(1 week, 5 weeks, 6 months)
  • Internet Gaming Disorder Scale-Short-Form(1 week, 5 weeks, 6 months)
  • The South Oaks Gambling Screen(1 week, 5 weeks, 6 months)

Study Sites (1)

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